Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma.

Abstract

Urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC) because of insufficient accuracy. This study evaluated a multiplex urine assay designed to accurately and noninvasively diagnose UTUC. Oncuria-Detect is a multiplex immunoassay capable of detecting urothelial cancer using a single voided urine specimen. In the current multi-institutional study, we tested the assay's utility in identifying UTUC in 60 subjects presenting for evaluation of upper tract mass compared with samples from 60 age-, sex-, and race-matched controls. Cancer status was confirmed by histopathological assessment of tissue specimens obtained during ureteroscopy/biopsy or at the time of definitive surgical intervention (nephroureterectomy or ureterectomy). For detecting UTUC, Oncuria-Detect provided an AUC of 0.77 (95% CI: 0.70-0.84) with an overall sensitivity of 93%, specificity of 55%, negative predictive value 89%, and positive predictive value 67%. Assay sensitivity values for low-grade, high-grade, noninvasive, and invasive UTUC were 94%, 93%, 93%, and 92%, respectively. Voided urine cytology showed an overall sensitivity of 54%, specificity of 100%, negative predictive value 31.0%, and positive predictive value 100%. Selective (upper tract) cytology had a sensitivity of 80%. Oncuria-Detect outperformed both noninvasive voided urinary cytology and invasive selective cytology in overall assay performance. Oncuria-Detect accurately identified and categorized UTUC and discriminated patients with cancer from nontumor-bearing individuals. The Oncuria-Detect test provides a rapid, accurate, and noninvasive method for detecting UTUC.